Good news for cancer immunotherapies in the US

On 23 June 2017 the United States Patent and Trademark Office (USPTO) announced that it will extend its Cancer Immunotherapy Pilot Program until 31 December 2018, prompted by a significant uptake of the pilot program introduced in June 2016. Further extensions have been flagged depending on participant feedback, continued interest and the effectiveness of the program.

The Cancer Immunotherapy Pilot Program was introduced by the USPTO on 29 June 2016 to fast-track patent applications directed to cancer immunotherapies as part of the US Government’s “National Cancer Moonshot” to eliminate cancer (see our previous article here).

Under the program, patent applications directed to cancer immunotherapy are eligible for expedited examination. Initially, the program was only scheduled to run for twelve months, expiring on 28 June 2017. However, with over 80 petitions filed and nine patents granted in this period, the USPTO has extended the program until 31 December 2018.

The eligibility requirements remain the same. Applicants must petition for “special status” and ensure their application contains one or more claims to a method for treating cancer using immunotherapy.

The fee-free program is open to:

any application that has not received a first Office Action;

any application where the petition is filed with a Request for Continued Examination (RCE); or

any application that is not under final rejection and where the claimed cancer immunotherapy is the subject of an active Investigational New Drug (IND) application that has entered Phase II or Phase III (FDA) clinical trials.

Applications which satisfy the requirements for special status will be fast-tracked to examination, with the aim of reaching a final decision on patentability within 12 months of special status being granted.

The Cancer Immunology Pilot Program provides a unique opportunity to expedite examination of applications relating to cancer immunotherapy. The extension of the program will be a welcome development for applicants seeking to commercialise or progress their novel immunotherapies through clinical trials.